- The Washington Times - Wednesday, December 2, 2020

The Trump administration said Wednesday that it expects two coronavirus vaccines to be approved before Christmas but isn’t moving up its deadlines after British regulators beat the Americans to the punch by approving Pfizer’s version first.

British authorities plan to start immunizing people next week with the vaccine developed by Pfizer and BioNTech, a German company, starting with elderly people in long-term care facilities and their health care providers.

The country has ordered 40 million doses, enough for 20 million people with the two-dose vaccine.

“Help is on the way. We can now see the way out,” British Health Secretary Matt Hancock told NBC’s “Today” show.

Experts told The Washington Times that British regulators likely moved so quickly because they relied heavily on company analyses versus their own reviews or were vetting data as they received it.

Countries have deployed different standards. Russia was moving to approve its vaccine, the Sputnik V, in August before phase three trials were conducted.

Shortly after the British announcement, Russian President Vladimir Putin told authorities to begin vaccinating Russians on a large-scale basis by next week.

China began inoculating citizens, mostly state workers, before the vaccines made inside the communist nation were fully tested. It has promised millions of doses to countries around the world.

Britain is the first country in the West to greenlight a vaccine. Some in the European Union criticized the move as hasty, while others said it would dial up the heat on U.S. regulators facing pressure from an impatient White House.

Health and Human Services Secretary Alex Azar put an upbeat spin on the British news by saying it bodes well for the process and uptake in the U.S.

“While the [Food and Drug Administration] completes its review, the approval of another independent regulatory body should give Americans additional confidence in the quality of the vaccine,” Mr. Azar said in a briefing on Operation Warp Speed, President Trump’s initiative to speed the approval of vaccines and therapies for COVID-19.

He said the FDA is still scheduled to discuss the Pfizer vaccine with an advisory panel on Dec. 10 and convene a similar meeting on Dec. 17 to discuss a second two-dose, messenger-RNA vaccine from Moderna.

Mr. Azar said vaccines from additional drugmakers are “well on their way” in the final stages of clinical trials, potentially increasing the number of available doses.

As it stands, officials estimate that they will vaccinate 20 million Americans before the end of the year, 30 million in January and 50 million in February, for a total of 100 million by the start of March.

“Of course, we’re all eager to have enough supply to vaccinate every American who wants it. Because of Operation Warp Speed, we expect to be at that point in the spring,” Mr. Azar said.

The Pfizer vaccine, which must be stored at ultra-low temperatures, is 95% effective in human trials and requires two injections, 21 days apart.

U.S. officials said they will allocate supply in a way that guarantees the second dose.

“Our responsibility is to make sure we have both doses in hand before we send the first dose out,” said Army Gen. Gustave Perna, who is overseeing the logistical effort.

The U.S. is racing to get vaccines into arms as COVID-19 surges across the country, with an average of 160,000 newly reported cases and 1,500 deaths per day. Hospitals are being stretched to the limit in some places as the U.S. death toll surpasses 272,000 and the number of cases approaches 14 million.

“The reality is, December and January and February are going to be rough times. I actually believe they’re going to be the most difficult time in the public health history of this nation, largely because of the stress that it’s going to put on our health care system,” Robert Redfield, director of the Centers for Disease Control and Prevention, told the U.S. Chamber of Commerce Foundation.

He said Americans need to take mask-wearing seriously. He cited a study that showed Kansas counties that mandated masks showed decreases in cases while those that didn’t had increases.

“The time for debating whether masks work or not is over. We clearly have scientific evidence,” Dr. Redfield said.

The CDC urged people to avoid travel over the holiday season but loosened quarantine guidance to try to improve compliance.

The CDC said people who are exposed to someone with COVID-19 can self-quarantine for 10 days, down from 14, if they don’t show symptoms. The period could be shortened to seven days with negative test results, the agency said.

CDC scientists said a full 14-day quarantine would eliminate all risk but “extensive modeling” of likely transmission guided their recommendation.

“Reducing the length of quarantine may make it easier for people to take this critical public health action,” said Henry Walke, the CDC’s coronavirus incident manager.

He said the shorter period is vital for people who are prevented from working during the longer, 14-day quarantine.

An advisory panel to the CDC said health care workers and staff and residents of long-term care facilities — a combined population of about 24 million — should be first in line once the vaccine is available.

Mr. Azar said governors will take the recommendations and refine them into “more precise” guidance for their respective states, based on the needs of their populations.

The CDC panel is expected to meet again to debate additional rounds of distribution. Essential workers outside of health care, seniors and those with underlying health conditions are expected to be next in line.

Operation Warp Speed’s science adviser, Moncef Slaoui, said enough doses should be available to immunize these high-priority groups by the end of February.

This article is based in part on wire service reports.

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